FDA.reportPublic FDA data

Children's Delsym

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:59:02

Label at a glance#

ProductChildrens Delsym Cough Plus Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age (year) Dose (mL) children 6 to under 12 years of age 5 mL - 10 mL every 4 hours children 4 to under 6 years of age 2.5 mL - 5 mL every 4 hours children under 4 ye...

Storage and handling

each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

OTC - WHEN USING SECTION

When using this product do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
Age (year)Dose (mL)
children 6 to under 12 years of age5 mL - 10 mL every 4 hours
children 4 to under 6 years of age2.5 mL - 5 mL every 4 hours
children under 4 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum

1 may contain this ingredient

Questions?

OTC - QUESTIONS SECTION

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-214-64

Ages 4 Years +

Children's

Delsym ®

COUGH + ®

Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

  • Relieves Cough
  • Relieves Chest

    Congestion
  • Thins &

    Loosens

    Mucus

Cherry Flavor

4 fl oz (118 mL) LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN9
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY9
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-214-642020-07-14C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM
63824-214-642020-07-14C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM
63824-214-662020-07-14C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM
63824-214-662020-07-14C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM
63824-214-642020-01-31C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM
63824-214-642020-01-31C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM
63824-214-662020-01-31C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM
63824-214-662020-01-31C16284748780-19d75b9d0-8c4d-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus ® Chest Congestion DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-214-64Childrens DelsymCough Plus Chest Congestion DM1 in 1 CARTONSOLUTION19
63824-214-64Childrens DelsymCough Plus Chest Congestion DM118 mL in 1 BOTTLESOLUTION1189
63824-214-66Childrens DelsymCough Plus Chest Congestion DM180 mL in 1 BOTTLESOLUTION1809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-214-64ML - Milliliter63824-2145ff14f69-6daf-4940-86c6-4b9f0e158c2512019-08-06
63824-214-66ML - Milliliter63824-214068170b2-d990-4c5d-b236-3955e5f55dee12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH2
GuaifenesinACTIVE INGREDIENT495W7451VQ2
DextromethorphanACTIVE MOIETY7355X3ROTS2
GuaifenesinACTIVE MOIETY495W7451VQ2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL2
edetate disodiumINACTIVE INGREDIENT7FLD91C86K2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
propyl gallateINACTIVE INGREDIENT8D4SNN7V922
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU2
sorbitolINACTIVE INGREDIENT506T60A25R2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD42
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95K2
waterINACTIVE INGREDIENT059QF0KO0R2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-21463824-214-66, 63824-214-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
XANTHAN GUMTTV12P4NEEIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-05-13weekly-update2026-06-03 18:02:48

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propyl gallatePROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
18 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
18 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii+route
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii+route
18 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
18 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
18 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
ndc (package): 63824-214-64
ndc (package): 63824-214-66
ndc (product): 63824-214
ndc11 (package): 63824021464
ndc11 (package): 63824021466
spl id: 52d107ce-dd04-515f-e063-6394a90a91dc
spl set id: d26b5143-aa07-4114-a6ba-4f503aadd46f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.